UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001948
Receipt number R000002372
Scientific Title The clinical study for the mechanism of pioglitazone-induced edema in patients with type 2 diabetes using a salt monitoring system
Date of disclosure of the study information 2009/05/08
Last modified on 2009/05/08 16:19:17

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The clinical study for the mechanism of pioglitazone-induced edema in patients with type 2 diabetes using a salt monitoring system

Acronym

The clinical study for the mechanism of pioglitazone-induced edema

Scientific Title

The clinical study for the mechanism of pioglitazone-induced edema in patients with type 2 diabetes using a salt monitoring system

Scientific Title:Acronym

The clinical study for the mechanism of pioglitazone-induced edema

Region

Japan


Condition

Condition

Type 2 diabetes

Classification by specialty

Medicine in general Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study to investigate the relationship between salt excretion and pioglitazone-induced edema

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Onset of edema

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

administration of pioglitazone (15mg/day)

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

75 years-old >

Gender

Female

Key inclusion criteria

Type 2 diabetic patients after obtaining written informed concent

Key exclusion criteria

1) Congestive heart failure or having a history of congestive heart failure
2) Severe ketosis, diabetic coma, or type 1 diabetes
3) Having a severe hepatic or renal dysfunction
4) Having a severe infection or injury, or during perioperative period
5) Having an allergic history of pioglitazone
6) Be pregnant or at risk of becoming pregnant
7) Receiving any diuretic medication
8) Evaluated as being inadequate by the physician-in-charge

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuo Terauchi

Organization

Graduate School of Medicine, Yokohama City University

Division name

Department of Endocrinology and Metabolism

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Graduate School of Medicine, Yokohama City University

Division name

Department of Endocrinology and Metabolism

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Graduate School of Medicine, Yokohama City University

Institute

Department

Personal name



Funding Source

Organization

Grants for the Strategic Research Project (K18005, K19004) of Yokohama City University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2009 Year 05 Month 08 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2006 Year 08 Month 18 Day

Date of IRB


Anticipated trial start date

2006 Year 10 Month 01 Day

Last follow-up date

2007 Year 09 Month 01 Day

Date of closure to data entry

2007 Year 09 Month 01 Day

Date trial data considered complete

2007 Year 09 Month 01 Day

Date analysis concluded

2008 Year 09 Month 01 Day


Other

Other related information



Management information

Registered date

2009 Year 05 Month 08 Day

Last modified on

2009 Year 05 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002372


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name